32 - Successful Virtual IRB Meetings

Background:  Virtual Institutional Review Board (IRB) meetings offer a flexible, regulatory-compliant, and efficient method for conducting operations, serving as a practical solution for both routine and emergency situations. Our impactful approach leverages the advantages of remote engagement while effectively addressing connectivity and protocol review challenges before, during, and after the meeting.

Program

Description:  We present a structured approach to virtual IRB meetings, ensuring compliance with regulations (45 CFR 46.111 / 21 CFR 56.111). Key features include: (1) (Shared or Individual) Role Assignments: Online agenda pre-reviewer, minute-taker, chat-tracker, time-keeper, meeting-moderator, and decision-letter writer. (2) Meeting Protocols: Roll call and attendee tracking to ensure quorum, confidentiality agreements to protect sensitive information, and digital access to meeting materials. (3) Technology Support: On-demand assistance to address connectivity issues, disruptions, or cross talk ensuring smooth meeting progression. (4) Post-Meeting Processes: Comprehensive record-keeping and follow-ups to ensure documentation integrity and compliance. Our strategies have led to improvements in meeting management and regulatory adherence, demonstrating their effectiveness in any virtual setting.

Program

Assessment:  In early 2020, like many IRBs, we transitioned to virtual meetings in response to shelter-in-place mandates. During this period, we faced challenges related to consistent attendance, connectivity issues, document access, and ensuring the confidentiality and security of discussions. We also encountered distractions during meetings, such as various device connections, cross-talk, audio/video disturbances, and concerns about the level of engagement of all attendees. As our Board membership expanded and we became accustomed to remote settings, we implemented refined strategies to enhance meeting efficiency. To assess the effectiveness of our virtual meeting Standard Operating Procedures (SOPs), we will present data on time management, utilization of virtual/digital tools, online agenda maintenance, quality assurance measures, and record-keeping practices.

Limitations: Our ability to report on and evaluate the effectiveness of our approach is somewhat constrained because we needed adequate staff for data recording, assessment, and evaluation. Consequently, our assessment is predominantly based on informal feedback, observations, and data accumulated within the past year, as our staff numbers have increased. Nonetheless, we offer templates, examples, and SOP excerpts that can be utilized to replicate and enhance our approach for implementation in other institutions.

Discussion:  Ensuring compliance with regulations and upholding quorum and membership representation is crucial whether meetings are conducted in person or virtually. Given our successful experiences with virtual settings, a complete return to fully in-person meetings seems unlikely. Our focus is on increasing attendee engagement, optimizing procedural workflows to ensure readiness and professionalism, and devising practical solutions to address any challenges that may arise online. As IRB staff become adept at conducting virtual meetings, we aim to streamline the process and provide reassurance to other meeting organizers and attendees about the possibilities of remote gatherings.